[Federal Register: December 12, 2003 (Volume 68, Number 239)]
[Page 69408-69409]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2002N-0276 and 2002N-0278]

Small Entity Compliance Guides on Registration of Food Facilities 
and Prior Notice of Imported Food; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of small entity compliance guides (SECGs) for the interim 
final rules on Registration of Food Facilities and Prior Notice of 
Imported Food issued under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act). Both 
interim final rules published in the Federal Register of October 10, 
2003. These SECGs are intended to help small businesses better 
understand the registration and prior notice regulations.

DATES:  Submit written or electronic comments on the SECGs at any time.

ADDRESSES:  Submit written comments concerning these SECGs to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments on the SECGs to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
    Submit requests for single copies of one or both SECGs to the Prior 
Notice help desk by telephone at 1-800-216-7331 (within the United 
States) or 301-575-0156 (outside the United States), by FAX: 301-210-0247, or by e-mail: furls@fda.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to these SECGs.

FOR FURTHER INFORMATION CONTACT:  Deborah Ralston, Office of Regulatory 
Affairs, Office of Regional Operations, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-6230.


I. Background

    In the Federal Register of October 10, 2003 (68 FR 58894 and 68 FR 
58974), FDA issued two interim final rules to implement sections 305 
(Registration of Food Facilities) and 307 (Prior Notice of Imported 
Food) of the Bioterrorism Act. The registration interim final rule 
requires domestic and foreign facilities that manufacture/process, 
pack, or hold food for human or animal consumption in the United States 
to register with FDA by December 12, 2003. The prior notice interim 
final rule requires the submission to FDA of prior notice of food, 
including animal feed, that is imported or offered for import into the 
United States beginning on December 12, 2003.
    We examined the economic implications of these interim rules as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
determined that they would have a significant economic impact on a 
substantial number of small entities.
     In compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121), we are making available 
these SECGs that explain the requirements of these regulations.
    FDA is issuing these SECGs as level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). These 
SECGs restate, in simplified format and language, FDA's current 
requirements for Registration of Food Facilities and Prior Notice of 
Imported Food. As guidance, these documents are not binding on either 
FDA or the public. FDA notes, however, that the regulations that serve 
as the

[[Page 69409]]

basis for these guidance documents establish requirements for all 
covered activities. For this reason, FDA strongly recommends that 
affected parties consult the regulations at 21 CFR part 1, subparts H 
and I, in addition to reading these SECGs.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding these SECGs. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the applicable docket number(s) 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain these SECGs at 

    Dated: December 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30738 Filed 12-11-03; 8:45 am]